510(k) Report

Devices descending from K031672

862 later devices reach Spinal Concepts, Inc. Infix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+8K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+8K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+8K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K230026SqualeImplanet, S.A.20230—
+9K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+9K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+9K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+9K201087CORBEL SpacersGlobus Medical, Inc.202036—
+9K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+9K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+9K182584Lucent® XPSpinal Elements, Inc.20183—
+9K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+9K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+9K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+9K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+9K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K243188Cylox® STSignus Medizintechnik GmbH20250—
+10K234150Lucent® XPSpinal Elements20240—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+10K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+10K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+10K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+11K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+11K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+11K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+12K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+12K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+12K192897icotec Cervical CageIcotec AG20201—
+13K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+13K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—